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Comparative Ergonomic Analysis of Robotic Versus Laparoscopic Surgery

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ClinicalTrials.gov Identifier: NCT01903577
Recruitment Status : Terminated
First Posted : July 19, 2013
Last Update Posted : November 21, 2018
Sponsor:
Collaborators:
Intuitive Surgical
Society of American Gastrointestinal and Endoscopic Surgeons
Southern Illinois University
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:

Robotic surgery holds the potential to overcome many of the ergonomic challenges posed by laparoscopic surgery. In this study, we propose to quantify this potential ergonomic benefit by measuring electromyography (EMG) and instrument motion analysis of subjects performing surgical tasks using robotic assistance versus standard laparoscopic instrumentation.

Hypothesis: We hypothesize that surgeons will experience significant, measurable ergonomic advantages when performing tasks using robotic surgery when compared to conventional laparoscopic tools.

Study design: Subjects for the study will include three groups of varying degrees of training - (1) novice laparoscopists/novice roboticists, (2) expert laparoscopists/novice roboticists, and (3) expert laparoscopsts/expert roboticists. Subjects will perform the following tasks (chosen based on their reliability and validity in previous studies). Each task will be performed with standard laparoscopic instrumentation and with the da Vinci Surgical System.

  • Inanimate (dry lab): Fundamentals of Laparoscopic (FLS) peg transfer, pattern cutting, intracorporeal suturing.
  • Animate (porcine lab): laparoscopic bowel resection and anastomosis, robotic bowel resection and anastomosis.
  • Human (clinical case): any laparoscopic or robotic procedure (preferably laparoscopic bowel resection and anastomosis, robotic bowel resection and anastomosis).

Outcome measures:

  • Time to completion of tasks
  • EMG: peak amplitudes, % maximum voluntary contraction and frequency analysis
  • NASA Task Load Index scores
  • Subject-Reported Qualitative Data from surveys
  • Quality analysis of tasks (e.g., pattern cutting accuracy, % knots tied securely) for dry lab and animate lab tasks only)
  • Instrument motion analysis of tasks (for dry lab and animate lab tasks only)

Condition or disease Intervention/treatment Phase
Ergonomics Other: Robotic Task Performance Other: Laparoscopic Task Performance Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comparative Ergonomic Analysis of Robotic Versus Laparoscopic Surgery
Study Start Date : September 2012
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ergonomics

Arm Intervention/treatment
Experimental: Novice Laparoscopic and Robotic Surgeons

Students and surgical trainees with less than 100 laparoscopic and less than 50 robotic cases.

Will participate in Robotic Task Performance and Laparoscopic Task Performance

Other: Robotic Task Performance
Subjects will perform FLS tasks on the robotic platform while EMG data is being collected. Task performance and NASA task load index will be assessed. Experts in robotic surgery will also perform operative cases while EMG is being collected.

Other: Laparoscopic Task Performance
Subjects will perform FLS tasks on the laparoscopic platform while EMG data is being collected. Task performance and NASA task load index will be assessed. Experts in laparoscopic surgery will also perform operative cases while EMG is being collected.

Experimental: Expert Laparoscopists, Novice Roboticists

Surgeons with more than 100 laparoscopic cases, less than 50 robotic cases.

Will participate in Robotic Task Performance and Laparoscopic Task Performance

Other: Robotic Task Performance
Subjects will perform FLS tasks on the robotic platform while EMG data is being collected. Task performance and NASA task load index will be assessed. Experts in robotic surgery will also perform operative cases while EMG is being collected.

Other: Laparoscopic Task Performance
Subjects will perform FLS tasks on the laparoscopic platform while EMG data is being collected. Task performance and NASA task load index will be assessed. Experts in laparoscopic surgery will also perform operative cases while EMG is being collected.

Experimental: Expert robotic and laparoscopic surgeons

Surgeons with greater than 100 laparoscopic and greater than 50 robotic cases.

Will participate in Robotic Task Performance and Laparoscopic Task Performance

Other: Robotic Task Performance
Subjects will perform FLS tasks on the robotic platform while EMG data is being collected. Task performance and NASA task load index will be assessed. Experts in robotic surgery will also perform operative cases while EMG is being collected.

Other: Laparoscopic Task Performance
Subjects will perform FLS tasks on the laparoscopic platform while EMG data is being collected. Task performance and NASA task load index will be assessed. Experts in laparoscopic surgery will also perform operative cases while EMG is being collected.




Primary Outcome Measures :
  1. %MVC [ Time Frame: At the time of Robotic and Laparoscopic Task Performance ]
    EMG: % maximum voluntary contraction will be calculated during each task repetition and surgical task


Secondary Outcome Measures :
  1. Completion time [ Time Frame: At the time of Robotic and Laparoscopic Task Performance ]
    Time to completion of tasks

  2. NASA Task Load Index [ Time Frame: At the time of Robotic and Laparoscopic Task Performance ]
    NASA Task Load Index scores in each of the six domains tested will be compared for laparoscopic and robotic surgical platforms

  3. Quality analysis of tasks [ Time Frame: At the time of Robotic and Laparoscopic Task Performance ]
    Quality analysis of tasks performed (pattern cutting accuracy, % knots tied securely) for dry lab tasks only



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

A) Novices Laparoscopists/Novice Roboticists

Inclusion Criteria:

  1. age> 18 years
  2. medical student, resident, fellow, or attending in Surgery, Urology, or Obstetrics-Gynecology at Washington University School of Medicine
  3. performance of <100 laparoscopic cases and <50 robotic cases during one's career as primary surgeon or first assistant surgeon

Exclusion Criteria:

  1. age <18 years
  2. known severe skin sensitivities or allergies to adhesives

B) Expert Laparoscopists/Novice Roboticists

Inclusion Criteria:

  1. age> 18 years
  2. resident, fellow, or attending in Surgery, Urology, or Obstetrics-Gynecology at Washington University School of Medicine
  3. performance of = or >100 laparoscopic cases during one's career and <50 robotic cases during one's career as primary surgeon or first assistant surgeon

Exclusion Criteria:

  1. age <18 years
  2. known severe skin sensitivities or allergies to adhesives

C) Expert Laparoscopists/Expert Roboticists

Inclusion Criteria:

  1. age> 18 years
  2. resident, fellow, or attending in Surgery, Urology, or Obstetrics-Gynecology at Washington University School of Medicine
  3. performance of = or >100 laparoscopic cases and = or >50 robotic cases during one's career as primary surgeon or first assistant surgeon

Exclusion Criteria:

  1. age <18 years
  2. known severe skin sensitivities or allergies to adhesives

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903577


Locations
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United States, Missouri
Washington University in St Louis School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Intuitive Surgical
Society of American Gastrointestinal and Endoscopic Surgeons
Southern Illinois University
Investigators
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Principal Investigator: Michael M Awad, MD, PhD Washington University School of Medicine

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01903577     History of Changes
Other Study ID Numbers: Robotic Ergonomics-201101766
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018

Keywords provided by Washington University School of Medicine:
Ergonomics
Robotic Surgery
Laparoscopic Surgery